Advice and Resources for the Biotech Industry

Advice and Resources for the Biotech Industry

Following an enthusiastic response to my summer reading list from last year, I decided to once again recommend a number of non-fiction, bioscience and medicine based books that I read this past year. The majority of these were recently published, although some are “oldies but goodies” that contain nicely written stories that are well worth your efforts to track them down. Here’s the list:Elixir: The American Tragedy of a Deadly Drugby Barbara J. Martin (2014) comprehensively details the elixir sulfanilamide drug poisonings in 1937. If you’re not familiar with that chapter in medical history, the S.E. Massengill Company of Bristol, Tennessee sold an elixir containing the antibiotic sulfanilamide. To increase the palatability of this solution for children, the company’s head chemist decided to add diethylene glycol to give the medicine a sweet flavor. Unfortunately, this flavoring agent is highly toxic, and the drug wound up killing more than 100 people, the majority of whom were children. This book is exhaustingly thorough in its reporting of the incident and its aftermath. It captures the stories of virtually every one of the victims as well as those involved in the production, distribution, and later round up of this poisonous concoction. This disaster paved the way for federal legislation that made it a requirement that drugs sold in the U.S. needed to demonstrate their safety before they could be peddled to consumers.

Dark Remedy: The Impact Of Thalidomide And Its Revival As A Vital Medicine by Trent Stephens and Rock Brynner (2001). This book traces the history of thalidomide, a drug developed during the 1950s that wound up being one of the most teratogenic agents (substances that cause birth defects) ever marketed. Unfortunately, this discovery only came after the drug had been sold for years, and children born of mothers who had taken this drug early in their pregnancies suffered from a variety of birth defects, including an unusual and profound one called phocomelia (malformation of the limbs). What sets this book apart from others that cover similar territory is the simultaneous examination of the aftermath of the scandal in multiple countries, and how difficult it was for patients to get, and journalists to share, information. Gag orders, especially in the U.K., prevented many people from finding out about the scandal for decades. While the drug was never sold in the U.S., more than 2.5 million tablets were distributed to over 20,000 patients as part of an “investigational program” run by the distributor’s marketing (not clinical) group. Finally, the book does a nice job of explaining how the most reviled drug in history wound up being used to treat people with leprosy, and eventually went on to became a mainstay in the treatment of multiple myeloma. If you like this one, you might want to follow it up by reading The Great Drug Deception: The Shocking Story of MER/29 and the Folks Who Gave You Thalidomideby Ralph Adam Fine (1972). This book details another drug fiasco associated with the Wm. S. Merrell Co. circa 1960-1962. MER/29 (strangely, the drug was never given a more conventional branded name) was marketed as “the first safe agent to inhibit body-produced cholesterol”. Unfortunately, once on the market the drug was found to be associated with several dangerous side effects, including severe skin changes (ichthyosis) and cataracts. An investigation revealed that scientific data submitted to the FDA had been falsified in order to win approval, and the company withdrew the drug. These two books paint a devastating portrait of what must be historically defined as the most ethically challenged (and incompetent) drug company in U.S. history.

Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck by Adam Cohen (2016) provides a nice historical review of the eugenics movement in the U.S. at the beginning of the 20th century. During that time period, many of America’s intellectual elite were worried that the greater reproductive rate of the poor and “feebleminded” would eventually destroy the intellectual capital of the nation. These days we use the terms idiot, moron, and imbecile interchangeably to describe those who support political candidates that we don’t favor. However, back in the day these terms were formally used to describe the varying levels of mental capacity of “feebleminded” individuals, even though the scientific validity of the test used to determine this was unsupported by anything approaching solid data. People who were “feebleminded” were marked for sterilization by state institutions, often with no one to advocate for them. In reality, the term “feebleminded” was often used as a descriptor for individuals who were uneducated, free spirited, promiscuous, or poor. The book does a nice job of describing the legal battles surrounding eugenics, which went all the way to the Supreme Court in a test case involving Carrie Buck (which she lost). The eugenics movement in America helped paved the way for the even more lethal program put in place by the Nazis in Germany.

Brain Storms: The Race to Unlock the Mysteries of Parkinson's Disease by Jon Palfreman (2015) is a well researched follow up to his previous book (co-authored with J.W. Langston) The Case of the Frozen Addicts: How the Solution of a Medical Mystery Revolutionized the Understanding of Parkinson's Disease. The earlier book looked at how a contaminant in an illegal batch of street drug led to a number of individuals developing severe cases of rapid onset immobility that resembled Parkinson’s disease. This discovery was incredibly useful in helping scientists define the disease anatomically. Ironically, Brain Storms begins when author Jon Palfreman is himself diagnosed with Parkinson’s disease. The book follows his subsequent journey visiting with bench scientists and physicians to understand the pathological basis of Parkinson’s disease. Along the way, he explores and explains a variety of clinical approaches that are being investigated to treat this devastating neurological disease.

Brave Genius: A Scientist, a Philosopher, and Their Daring Adventures from the French Resistance to the Nobel Prize by Sean B. Carroll (2014) recounts a chapter of science history that I was unfamiliar with. Those of us who have worked in the lab as scientists sometimes bemoan our lack of funding, or some other trivial issue that make our tasks at the bench harder. Imagine trying to do biological research in France at the outbreak of World War II while the country is being crushed by the invading Nazis. This was the challenge that Jacques Monod faced, and he wound up being a leader of the French underground (and later a Nobel Prize winning scientist). Monod befriended the writer Albert Camus (another eventual Nobel laureate), and their friendship helps inspire their efforts to disrupt the Vichy government and eventually helped lead to the liberation of France. The book also details Monod’s efforts to help scientists escape from behind the Iron Curtain after the war. Monod is mostly widely known for his science experiments (along with his collaborator Francois Jacob) that defined the concept of the operon in bacteria. As this book makes clear, however, he was admired in France every bit as much for his efforts to disrupt the German army during WWII as for his scientific achievements. Jacob (who fought during the war with the free French forces under Charles de Gaulle) also comes across as a heroic character in this entertainingly written book.

The Death of Cancer: After Fifty Years on the Front Lines of Medicine, a Pioneering Oncologist Reveals Why the War on Cancer Is Winnable--and How We Can Get There by Vincent T. DeVita and Elizabeth Devita-Raeburn (2015). This book is an interesting career retrospective written by one of the big names in the war on cancer: Vincent DeVita. I was a bit surprised by the tell-all nature of the book; DeVita is not afraid to identify both colleagues and institutions that he didn’t have much respect or admiration for, and he names names to point out particular cancer programs that, despite their hype, were not providing top-level care. Like many others I question his conclusion that we are getting close to winning the war on cancer, but DeVita does a nice job of highlighting advances over the year, particularly in the treatment of blood cancers using combinations of chemotherapy drugs that he helped to pioneer. A nice historical look-back, and it also includes some interesting stories about how the war on cancer has been funded over the years.Ending Medical Reversal: Improving Outcomes, Saving Lives by Vinayak K. Prasad and Adam S. Cifu (2015). The problem is a familiar one to many of us who follow the health and medicine field. We learn about how some particular treatment is useful for some particular disease, only to find out years later that the opposite is true, and that the original data was based on some misleading information and is no longer believed to be true. Examples include the “benefits” of using of estrogen replacement therapy in post-menopausal women, and the PSA test used in prostate cancer screening. The authors argue (successfully) that too many techniques and approaches become widely adapted in clinical medicine without having a robust amount of data that supports their use. Their subsequent withdrawal (when they are shown not to be effective treatments) acts to undermine patient’s confidence in medicine in general and their doctors in particular.

The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine's Computer Age by Robert Wachter (2015) is focused on the efforts to bring computerization into medicine and health care. It extensively recounts the problems that occurred when medical practices tried to switch over from hand written patient notes to electronic health records, and why this didn’t go so smoothly. The book will disabuse you of any thoughts that digitalization, on its own, is going to eliminate medical errors and make patients safer. A complex topic very clearly explained.

The Patient Will See You Now: The Future of Medicine is in Your Hands by Eric Topol (2015) is all about change happening throughout our medical system. Eric Topol is a super bright physician, and the book is detailed and very well written. However, I did not buy his arguments that patients are going to be in charge of their own health care, and that the “doctor knows best” approach of the past is going to fall by the wayside in the next few years. I agree that cell phones are going to be very helpful in some settings to help patients monitor their health status, but I don’t believe it is going to revolutionize medicine anytime soon. Adoption of the type he is talking about, in my experience, occurs much more slowly than he is predicting. Topol also suggests that the availability of enormous patient datasets will rapidly lead to improvements in health care. His arguments are well written and explained, but I think he is way too optimistic in envisioning a rapid transition from traditional roles (where the doctors run the show) into a more consumer centric model that puts the patients in charge.

The Brain That Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science by Norman Doidge (2007) was interesting, but to my mind it was focused on a singular note. Our brains are “plastic”, and they can be re-wired as a result of any number of events or inputs. It recounts a number of clinical stories of how patients were suffering from some type of neurological problem, and were eventually able to see some degree of improvement because their brains were able to rewire themselves, at least to some degree. I thought it could have used some additional discussions around the limitations of neuroplasticity, but still, an entertaining read.

Finally, I can strongly recommend The Gene: An Intimate History by Siddhartha Mukherjee (2016). This lengthy tome (500 plus pages) looks at the concept of the gene, with historical stops in the labs of all of the great thinkers. The book is incredibly well written, and even with an absence of figures it would make a stellar book for graduate students in molecular biology or genetics. The author weaves in stories of his own family history, which helps to make this somewhat more approachable. Mukherjee focuses on the key questions that arose at different points of history, putting into context what was (or was not) known at the time, and technically what tools and methods were available (or not) to answer the questions. Significant space is devoted to the ethical considerations that should be addressed around genetics and heredity, including a history of eugenics and the dilemma presented by the development of gene-modifying technologies such as CRISPR. The book is a worthy successor to his previous effort to explain cancer and cancer research, the Pulitzer Prize-winning The Emperor of All Maladies.

Happy reading!

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